Home Applications 020908 Application 020908
Type NDA
Sponsor NOVO NORDISK INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VAGIFEM ESTRADIOL TABLET;VAGINAL 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 VAGIFEM ESTRADIOL TABLET;VAGINAL 10MCG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020908-001 VAGIFEM ESTRADIOL 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 N020908-002 VAGIFEM ESTRADIOL 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020908-002 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020908-001 VAGIFEM 25MCG TABLET / VAGINAL RLD 1999-03-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020908-001 VAGIFEM 25MCG TABLET / VAGINAL RLD 1999-03-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / VAGINAL RLD 1999-03-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / VAGINAL RLD 1999-03-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0169-5176 Vagifem estradiol Novo Nordisk NDA Current 0169-5176 Vagifem estradiol Novo Nordisk NDA Current 0169-5176 Vagifem estradiol Novo Nordisk NDA Current 0169-5176 Vagifem estradiol Novo Nordisk NDA Current 0169-5176 Vagifem estradiol Novo Nordisk NDA Current 0169-5176 Vagifem estradiol Novo Nordisk NDA Current 69238-1524 Yuvafem Estradiol Amneal Pharmaceuticals NY LLC NDA AUTHORIZED GENERIC Current 69238-1524 Yuvafem Estradiol Amneal Pharmaceuticals LLC NDA AUTHORIZED GENERIC Current 69238-1524 Yuvafem Estradiol Amneal Pharmaceuticals NY LLC NDA AUTHORIZED GENERIC Current